Product information

From Health Canada

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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Cancelled Post Market

Current status date:

2016-09-26

Original market date: See footnote 1

2012-05-01

Product name:

FERAHEME

Description:

FOR I.V. USE ONLY. 510MG/17ML SINGLE USE VIALS

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02377217

Product Monograph/Veterinary Labelling:

Date: 2015-06-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

AMAG PHARMACEUTICALS INC
1100 Winter Street
Waltham
Massachusetts
United States 02415

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

20:04.04 

Anatomical Therapeutic Chemical (ATC): See footnote 4

B03AC IRON, PARENTERAL PREPARATIONS

Active ingredient group (AIG) number:See footnote5

0108536002

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
IRON (FERUMOXYTOL) 30 MG / ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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